Human Genetics: Key US regulatory and advisory bodies 19/7/02. By Deirdre Janson-Smith The key US agencies concerned with human genetics and genetic engineering form part of the US Government Department of Health and Human Services (DHHS), including the National Institutes of Health (NIH), the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC).

Within these bodies, specific committees and offices deal with different aspects of the field. The NIH houses the Recombinant DNA Advisory Committee (RAC), the Secretary's Advisory Committee on Genetic Testing (SACGT) and the US Government's Office for Human Research Protections (OHRP). The Center for Biologics Evaluation and Research (CBER) operates under the FDA. The CDC incorporates the Office of Genetics and Disease Prevention (OGDP). The Patent and Trademark Office deals with all gene and other biotechnology patenting issues. In addition, the President's Council on Bioethics is an independent advisory body providing a forum for debate on modern genetics and biotechnology.

The National Institutes for Health (NIH)

NIH conducts medical research in its own laboratories; supports the research of non-Federal scientists in universities, medical schools, hospitals and research institutions throughout the country and abroad, and fosters communication of medical information.

It incorporates:

• The National Human Genome Research Institute (NHGRI) - NHGRI leads the Human Genome Project for the NIH and supports genomic science worldwide. The Ethical Legal and Social Impact (ELSI) program at NHGRI funds and manages studies related to the ethical, legal and social implications of genetic and genomic research, and supports workshops and policy conferences on these topics.
• Recombinant DNA Advisory Committee (RAC) - RAC oversees gene therapy research. It was established by the NIH as a public forum for discussions on the safety of manipulation of genetic material through recombinant DNA techniques in. All its information is made public.
• Secretary's Advisory Committee on Genetic testing (SACGT) - SACGT has a wide remit to provide policy advice to the Department of Health and Human Services on the medical, ethical, legal and social issues raised by genetic testing. It issues guidelines, assesses risks and benefits, advises on issues of privacy and confidentiality, and on the adequacy of protective regulatory framework/bodies. In 2002, the US Department of Health and Human Services announced that the SACGT would be dismantled, and a new Secretary's Advisory Committee on Human Research Protections would be established.
• The Office for Human Research Protections (OHRP) - OHRP oversees and enforces Federal regulations on the protection of human subjects for all research funded through the DHHS. Any embryonic tissue is regarded as a human subject. Reproductive and therapeutic cloning research is banned in the USA, as is all stem cell research unless done on already existing stem cell lines. (NB Individual agencies and departments such as the FDA and Department of Energy also provide guidance to policy and regulations for any researchers they fund.)
• National Human Research Protections Advisory Committee (NHRPAC) – NHRPAC provides expert advice and make recommendations on issues related to the protection of human research subjects, to the Secretary and Assistant of HHS, the Director of the Office for Human Research Protections (OHRP), and other departmental officials.

The FDA

The Food and Drug Administration is responsible for promoting and protecting the public health by monitoring the development and subsequent safety of marketed food and cosmetics, pharmaceuticals and biological products (such as blood and vaccines) and medical devices for human use, as well as in veterinary medicine.

It incorporates:

• The Center for Biological Evaluation and Research (CBER) - CBER regulates human gene therapy products and NIH-funded studies into them. Genetic tests, testing kits and gene therapy products come under the category of medical devices and biological products, and so are subject to FDA licensing.
• The Centers for Disease Control and Prevention (CDC) - CDC is the lead agency for protecting the health and safety of the public, concerned with disease prevention and control, environmental health, and health promotion and education. It incorporates:
  The Office of Genomics and Disease Prevention (OGDP) - OGDP was set up in 1997 to integrate advances in human genetics into public health research, policies, and programs. It participates in national policy-setting panels, supports research. It educates and trains health professionals about the role of genetics in disease prevention, and keeps them informed on current understanding of the impact of human genetic research on disease prevention and health promotion.

President's Council for Bioethics

President Bush is advised independently by the President's Council for Bioethics. The Council's purpose is to advise on ethical issues related to advances in biomedical science and technology:

• to undertake fundamental inquiry into the human and moral significance of developments in biomedical and behavioural science and technology
• to explore specific ethical and policy questions related to these developments
• to provide a forum for a national discussion of bioethical issues
• to facilitate a greater understanding of bioethical issues
• to explore possibilities for useful international collaboration on bioethical issues.